Category: News & Comments

Vertex: Good News and Good Decisions

Vertex: Good News and Good Decisions

Vertex’s Good News Vertex and Kymera Therapeutics Collaboration Last week Vertex Pharmaceuticals (VRTX) and Kymera Therapeutics entered into a four-year strategic research and development collaboration to advance small molecule protein degraders against multiple targets. Kymera is an expert in targeted protein degradation and has its own drug discovery program known as Pegasus™. The collaboration will benefit from this program and from Vertex’s scientific, clinical and regulatory capabilities …
Advaxis: Why This Small Firm’s Stock Outperformed on a Negative Market Day

Advaxis: Why This Small Firm’s Stock Outperformed on a Negative Market Day

Advaxis Outperformed on a Negative Market Day ADXS Outperformed Advaxis’ (ADXS) stock rallied today as the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on its product AIM2CERV (axalimogene filolisbac). The product is in a Phase 3 clinical trial on patients with high-risk locally advanced cervical cancer. In its letter the FDA acknowledged that the Company has satisfactorily addressed all hold questions.  The Story …
Will the Bear Escape Tonight from the Market? Regeneron and Severe Asthma Patients Good News

Will the Bear Escape Tonight from the Market? Regeneron and Severe Asthma Patients Good News

The Stock Market The Confused and Confusing Stock Market The stock market is confused and confusing. No analysts’ speculations are materializing and no satisfactory explanations for the market’s agitation and selloff. Although not an unprecedented situation, what makes it strange and more puzzling than previous market’s selloffs is that it is happening at a time when all the prerequisites of a healthy economy exist. Historically …
Bluebird bio and Celgene: Encouraging Clinical Trial Results for Last Resort Multiple Myeloma Treatment

Bluebird bio and Celgene: Encouraging Clinical Trial Results for Last Resort Multiple Myeloma Treatment

A Great Day for Bluebird bio and Celgene Read the Clinical Trial Results for Myeloma What a Great Day! Jobs reaching the moon. Inflation not yet showing any concerning signs. A fiercely rebounding stock market. Those who are still listening to pessimistic opinions are missing the fact that technologies and biotechnology are standing at the starting line. They are not yet at the finish line. …
Exelixis and Aerie Have Good News

Exelixis and Aerie Have Good News

Exelixis & Aerie Have Good News Exelixis’ Good News about Cabometyx Takeda Pharmaceuticals applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and to sell Exelixis’ (EXEL) product Cabometyx® (cabozantinib) for unresectable and metastatic renal cell carcinoma (RCC) in Japan. The submission brings $10 million in milestone payments to Exelixis from Takeda in the second quarter of 2019. Takeda’s application …
Gilead and insitro announce strategic collaboration to discover and develop novel therapies for NASH

Gilead and insitro announce strategic collaboration to discover and develop novel therapies for NASH

Gilead and insitro Collaborate to Discover and Develop Novel Therapies for NASH using ISH Gilead Sciences (GILD) and insitro entered into a strategic collaboration to discover and develop treatments for nonalcoholic steatohepatitis (NASH). NASH A chronic form of liver disease characterized by excess fat in the liver, inflammation, and liver cell damage. Inflammation and liver cell damage can cause scarring of the liver or fibrosis. Ultimately leading …
Regeneron and Alnylam collaborative agreement will benefit these firms so why the selloff of both?

Regeneron and Alnylam collaborative agreement will benefit these firms so why the selloff of both?

Regeneron and Alnylam Agreement Will Benefit. Why the Sell-Off? Regeneron Pharmacueticals Founded, and led for 30 years, by physician-scientists Regeneron Pharmaceuticals (REGN) demonstrates an exceptional ability to translate science into medicine. Working diligently Regeneron succeeded in putting seven treatments in the hands of specialists in clinics around the world. Additionally, the firm managed to build a rich pipeline of numerous investigational products; all of which were …
Sangamo’s stock price Soars 52% in pre-market hours on hemophilia A trial results

Sangamo’s stock price Soars 52% in pre-market hours on hemophilia A trial results

Sangamo Therapeutics’ (SGMO) stock soared more than 52% in pre-market trading following the announcement, with Pfizer (PFE), of interim data from Phase 1/2 Alta study evaluating the firm’s gene therapy product SB-525 for severe hemophilia A.  The Product, SB-525 SB-525 comprises a recombinant adeno-associated virus serotype 6 vector (AAV6) encoding the complementary deoxyribonucleic acid for B domain deleted human FVIII. The SB-525 vector cassette was …
Aimmune Therapeutics’ product AR101 for the treatment of peanut allergy confirmed in Europe with previous successful results in the U.S.

Aimmune Therapeutics’ product AR101 for the treatment of peanut allergy confirmed in Europe with previous successful results in the U.S.

While waiting for Mueller’s report we stopped speculating on the stocks in what we saw as an unreadable market. Following the delivery of the Mueller report we hesitated to prophesy as we waited to see how the market would perform and the reasons for its performance. We usually try to speculate about the performance of biotech firms’ stocks based on their scientific capabilities, including their …
The FDA approves the first ever postpartum depression product. Positive results from Dermira’s atopic dermatitis product Lebrikizumab

The FDA approves the first ever postpartum depression product. Positive results from Dermira’s atopic dermatitis product Lebrikizumab

News We Loved to Hear  The First and Only Approval of a Specific Product for Postpartum Depression ZULRESSOTM The FDA granted approval of Sage Therapeutics’ (SAGE) ZULRESSOTM (brexanolone) injection. A product for the treatment of the condition known as postpartum depression (PPD). This makes Zulresso the first and only medicine specifically approved by the FDA to treat PPD; the most common medical complication of childbirth. The product …
Atossa Genetics’ news that staged a huge Rally of this small firm’s stock

Atossa Genetics’ news that staged a huge Rally of this small firm’s stock

Atossa Genetics (ATOS) announced that the FDA has issued a “Safe to Proceed” letter under their “expanded access” program permitting the use of Atossa’s oral Endoxifen as a post-mastectomy treatment in a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient. The patient completed a 3-week course of Atossa’s oral Endoxifen prior to her surgery under an FDA-approved expanded access program. Atossa’s stock rallied from under $2 to …
Spark Therapeutics to be acquired by Roche at $113.47 UP $61.91 

Spark Therapeutics to be acquired by Roche at $113.47 UP $61.91 

We congratulate our subscribers who kept Spark Therapeutics (ONCE) in spite of the stock’s kind of paralysis for no serious reasons. Spark, a fully integrated, commercial gene therapy company, announced today that it has entered into a definitive merger agreement with Roche (RHHBY). The firm is to fully acquire Spark Therapeutics at a price of $114.50 per share, in an all-cash transaction. This move represents  a total equity value …
Merck’s product Keytruda and Exelixis’ product Cabometyx are both winners

Merck’s product Keytruda and Exelixis’ product Cabometyx are both winners

Keytruda and Cabometyx Are Both Winners Keytruda failed to meet co-primary endpoints in Pivotal Phase 3 trial The pivotal Phase 3 KEYNOTE-240 trial evaluating Keytruda, Merck’s (MRK) checkpoint inhibitor anti-PD-1 therapy plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival …
RegenxBio: An analyst and investor event focused on the firm’s ophthalmology program.

RegenxBio: An analyst and investor event focused on the firm’s ophthalmology program.

RegenxBio (RGNX), a clinical-stage gene therapy firm with a proprietary NAV® Technology Platform, will host an analyst and investor event focused on its ophthalmology program; including its lead product candidate RGX-314, on Thursday, February 21, 2019, from 9:00 a.m. to 12:00 p.m. EST in New York City. A live webcast will be available on the company’s website. The agenda will include discussion on RegenxBio’s NAV® Technology Platform, a review of the market landscape and unmet need …
Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

The United States FDA granted AMT-061 Breakthrough Therapy Designation and The European Medicines Agency gave it access to the Priority Medicine (PRIME) regulatory initiative. Gene therapy firm, uniQure (QURE), announced updated clinical data in patients treated in the ongoing Phase 2b study of AMT-061; an investigational AAV5-based gene therapy containing a patent-protected  FIX9-Padua (Factor 9) for the treatment of patients with severe and moderately severe hemophilia B. The announced data, which …
RegenxBio product RGX-181 has been granted FDA Rare Pediatric Disease Designation for Batten Disease Condition known as CLN2

RegenxBio product RGX-181 has been granted FDA Rare Pediatric Disease Designation for Batten Disease Condition known as CLN2

FDA Granted Rare Pediatric Disease Designation for RegenxBio’s Product RGX-181 for CLN2 RegenxBio RegenxBio (RGNX), a development-stage firm that focuses on designing and developing gene therapy based on its proprietary NAV® Technology Platform, announced that the U.S. FDA granted Rare Pediatric Disease Designation to its RGX-181 therapy. RegenxBio is a leading clinical-stage biotechnology company that promises to cure genetic-derived diseases with its gene therapy. RegenxBio’s NAV Technology Platform is …
OncoCyte liquid biopsy proves its accuracy and superiority in the differential diagnoses of Lung Cancer

OncoCyte liquid biopsy proves its accuracy and superiority in the differential diagnoses of Lung Cancer

Can a liquid biopsy test be accurate enough for physicians to rely on in differentiating between malignant and benign lung nodules in early stage lung cancer and probably other cancers?  A Yes answer has come out from OncoCyte Corporation (OCX) which announced positive results from its key R&D Validation study demonstrating the accuracy of the Company’s DetermaVu™ liquid biopsy test for lung cancer.  The R&D Validation study …
CompuGen demonstrates the importance of its product COM701 targeting PVRIG in immunotherapy

CompuGen demonstrates the importance of its product COM701 targeting PVRIG in immunotherapy

Data published in Cancer Immunology Research indicate monotherapy and combination opportunities for COM701, a first-in-class cancer immunotherapy antibody targeting PVRIG CompuGen (CGEN) announced the online publication of preclinical data demonstrating the role of PVRIG as a novel immune checkpoint and the potential of its first-in-class inhibitory antibody product COM701 targeting PVRIG, to serve as an effective cancer immunotherapy. The findings were published in two peer-reviewed papers in …
Another drug approval for Exelixis. Why Alnylam’s stock is under pressure today

Another drug approval for Exelixis. Why Alnylam’s stock is under pressure today

More good news came  from Exelixis (EXEL). It was expected by many but not by those who ignore the good news in favor of any negative news or lack of news. The announced news is that the FDA approved Exelixis’ Cabometyx® (cabozantinib) for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. More good news is Exelixis’ announcement that the firm is prepared to fully support the …
Why the new approval of Exelixis’ blood pressure drug Minnebro in Japan is important

Why the new approval of Exelixis’ blood pressure drug Minnebro in Japan is important

Exelixis collaborator, Daiichi Sankyo, Receives Regulatory Approval for MINNEBRO™ (Esaxerenone) Tablets for Hypertension in Japan Exelixis (EXEL) and Daiichi Sankyo announced that the the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Minnebro™ (esaxerenone) tablets of ,1.25 mg, 2.5 mg, and 5 mg, for hypertension. Minnebro was identified during a prior research collaboration between Exelixis and Daiichi Sankyo, which was entered into in March 2006. The product has been subsequently developed …