–The Agreement Covers the Development of Investigational Plasma Kallikrein Inhibitors for Diabetic Macular Edema (DME) – Upfront Fee ($37 Million).  Potential Milestone Payments. Royalties On Sales. The deal could be worth $750 million – Merck Acquires 9.9% Stake in KalVista in Private Placement.    -Phase 2 Clinical Trial for the Investigational Intravitreal DME Candidate KVD001 Still Planned to Initiate in 2017. Surprise? Indeed, it is. KalVista Pharmaceuticals …

On November 2, 2017 Mannkind (MNKD) announced that the FDA has approved an update to its inhaled insulin product Afrezza prescribing information to include new clinical data that were presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016. Afrezza (human insulin) inhaled powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes …

Realizing the dream of approval of a small biotech’s lead drug would usually lead a small development-stage firm to either walking on the road to more achievements and growth, or walking in place doing nothing but spending its revenues while no dream materializes. We have seen both possibilities occur time and time again.     Seattle Genetics (SGEN) is now a revenue generating biotech. The firm, which …

Exelixis (EXEL) announced that Daiichi Sankyo (“Daiichi Sankyo”) reported positive top-line results from a phase 3 pivotal trial of esaxerenone for essential hypertension in Japan. The product is the fruit of the collaboration agreement signed by both firms back in 2006. The Story More than ten years ago, in March 2006, Daiichi Sankyo and Exelixis signed a research collaboration agreement to discover, develop and commercialize …

Agenus (AGEN) announced that the U.S. Food and Drug Administration (FDA) Advisory Committee voted unanimously, recommending the approval of GlaxoSmithKline’s (GSK) shingles vaccine candidate, Shingrix, containing Agenus’ proprietary immune adjuvant, QS-21 Stimulon®. This is good news for Agenus. As Garo Armen, Ph.D., Agenus CEO and Chairman of the Board said, “The Advisory Committee’s recommendation for the approval of Shingrix marks the first for a product …

Mirati Therapeutics (MRTX) announced positive preliminary data from two ongoing clinical trials of its product sitravatinib in non-small cell lung cancer (NSCLC). Combination of sitravatinib and Bristol Myers Squibb (BMS) checkpoint inhibitor Obdivo (nivolumab) might have broken the resistance against the immunotherapy checkpoint inhibitor drug in NSCLC patients with documented progression following prior checkpoint therapy. The results of the combination sitravatinib/nivolumab demonstrated 3 confirmed Partial …

Amicus (FOLD) announced the failure of its topical wound-healing product SD-101 for patients with epidermolysis bullosa (EB). The drug failure was revealed when top-line results from the randomized, double-blind, placebo-controlled Phase 3 clinical ESSENCE study SD-101 were announced. The results showed that the drug did not demonstrate a statistically significant difference from placebo in the intent to treat (ITT) population. The first primary endpoint results …

Indeed, updated data from the ongoing Phase 2 NLG2103 study of NewLink Genetics (NLNK) IDO inhibitor immunotherapy product indoximod in combination with the PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab) demonstrate positive results in advanced melanoma. The news rallied the stock that has been cremated following news that the same drug Indoximoll has failed to meet the endpoint in mid-phase trials on breast cancer in combination with …

Portola Portola Pharmaceuticals (PTLA) announced that it will host a webcast and conference call to provide an update on its anticoagulant Factor Xa inhibitor Bevyxxa® (betrixaban) launch plans, the validation of the commercial manufacturing process and drug release timing. Conference Call Details: The live conference call will be held today, Tuesday, September 5, 2017, at 4:30 p.m. Eastern Time (1:30 p.m. PT). It can be accessed by …

The answer is, indeed, Gilead (GILD) and its CAR T drug approval will be for non-Hodgkin lymphoma (NHL). This is true, as in May, the FDA has accepted for priority review Kite Pharma’s Biologics License Application (BLA) for its genetically engineered Chimeric Antigen Receptor T Cell (CAR-T) product axicabtagene ciloleucel. The submission follows positive data demonstrated after a single infusion of axicabtagene ciloleucel in the …

When what you predicted, preached, and wished are realized, this is good news. Today’s news is bringing all Prohost predictions into realization, Yes, Kite (KITE) is on its way to be acquired by Gilead (GILD) and yes both stocks have rallied and yes Juno (JUNO) is also rallying on the Kite’s news because both firms are pioneers in the CAR-T Immunotherapy technology and drugs. Rallied …

Xoma (XOMA) stock rallied surprising many but not all. We put this firm in a special table called aggressive portfolio where we put of firms with strong scientific and technological fundamentals that, for bad reasons, or trials and errors reasons have underperformed. With all its past history where past management’s sins overshadowed its science and scientists’ obvious clear capabilities, we never kicked XOMA out of …

New Discoveries in Neurodegenerative Diseases  Everyday is another day that can totally differ from the previous day with regard to increasing researchers’ capabilities of discovering new pathways of diseases and turning their new discoveries into far-reaching treatments. The tireless revolution in life sciences has uncovered treasures of knowledge that has been buried for centuries in the graves of the unknown. The wealth of knowledge being …

EXELIXIS Exelixis’ (EXEL) shareholders know well how good are the firm’s announced financial results for the second quarter of 2017. They also know well how good is the update presented by the firm about the progress made towards fulfilling its commercial and clinical development milestones. Exelixis report left no reason for complaining, criticizing or downgrading the firm’s stock. As a matter of fact, the presentation …

CELGENE Good news from Celgene (CELG) announced  that the FDA approved the firm’s targeted drug Idhifa (enasidenib) for adults with relapsed or refractory acute myeloid leukemia (AML) associated with isocitrate dehydrogenase-2 (IDH2) mutations. Good news also announced that the FDA approved the RealTime IDH2 companion assay, which pinpoints the IDH2 mutations. Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement. …

It took only a few months after the dosing stages of NKTR-358 in in a Phase I trial for Eli Lilly to strike a deal worth $400 million with the ascending firm Nektar (NKTR) related to the drug. Eli Lilly seemed impressed with NeKtar’s drug, which was designed to treat autoimmune and other chronic inflammatory conditions. NKTR-358 targets interleukin (IL-2) receptor complex. Nektar and Lilly …

IMPROVING ON CAR IMMUNOTHERAPY APPROACH  When we stated that chimeric antigen receptor CAR immunotherapy process was created to remain and improve, we aimed at demonstrating our conviction that the CAR approach will eventually be improved and become the gold standard for the treatment of many cancers. We observed that many research and medical institutions are using all advanced information, state-of-the-art techniques and technologies in order …

A BIG YES for Novartis CAR-T product has come from the  Food and Drug Administration (FDA) advisory committee. The committee recommended FDA approval for Novartis product CTL019 for pediatric acute lymphoblastic leukemia. The Vote: The panel voted 10-0 in favor of approval. Chimeric antigen receptor T-cell therapy, (CAR-T- Cell therapy) is an immunotherapy that enables the immune system T cells to seek, reach and attack cancer …

Merck’s (MRK) anti-PD-1 drug Keytruda® (pembrolizumab) is approved for many, many cancers. Yet, it is fair to say that this checkpoint inhibitor drug will not be effective in all cancers. This is especially true now that yesterday, the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of Keytruda® with Celgene’s products Pomalyst Pomalidomide and …

The most important last barrier to cross or dismantle for drug developers is the approval of novel products that amplify the improvement of previous drugs. The approvals of drugs in the U.S. and Europe open the door for the same drugs to be approved and marketed in the rest of the world. For the revenue-generating firms, each and every approval helps grow their revenues. With …