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 …

Aerie Pharmaceuticals (AERI) announced results from a double-masked, randomized, placebo-controlled study designed to evaluate the effect of its glaucoma product Rhopressa® (netarsudil ophthalmic solution) 0.02% on aqueous humor dynamics in patients with open-angle glaucoma or ocular hypertension. This study is the first performed on glaucoma patients to confirm that Rhopressa® lowers intraocular pressure (IOP) primarily through trabecular meshwork outflow facility.  In the trials, the enrolled patients …

Prohost Letter #416 Part 1 The Year In Review - 2017 Unheard of Programs - AN AWESOME YEAR for the biotech sector regarding its accomplishments. Many of the accomplished programs were unheard of regarding the degree of their positive impact on medical practice. Unfortunately, many of these accomplishments, which included the making of new discoveries, the creation of novel advanced technologies and the design of …

Two months ahead of the PDUFA date scheduled for February 28, 2018, the Food and Drug Administration (FDA) approved Aerie Pharmaceuticals’ (AERI) ophthalmic solution) 0.02% Rhopressa® (netarsudil for the lowering of elevated intraocular pressure (IOP) in open-angle glaucoma. Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie said that the firm will hire a sales force of 100 sales representatives early in the first quarter of …

Prohost Letter #414 GIANTS & DWARFS - We believe it’s a useful idea bringing The Week in Review into the Prohost Letter this time. We thought it would be easier for the readers to get last week’s updates and comments together with the Letter’s subjects and its Prohost Portfolio’s observations. In the Week that said au revoir, things happened that are worth citing. New development-stage …

The Week in Review #5 ALNYLAM (ALNY) and Sanofi Genzyme, the specialty care global business unit of Sanofi announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic for hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at …

PTC THERAPEUTICS Why Buying Emflaza? Buying Emflaza, a steroid approved by the FDA for Duchenne muscular dystrophy (DMD) from Marathon Pharmaceuticals invited an intractable headache to PTC Pharmaceuticals’ shareholders and scrutiny by some law makers. The cause of the law makers’ involvement has been the Marathon’s pricing Emflaza at $89,000, but PTCT shareholders had several question marks revolving around the motive for buying this drug …

Prohost Letter #400 NEAR-­TERM INVESTING The Prohost Letter #399 Part 3 has Promised to Des

As we expected in our previous articles, Today, Aerie Pharmaceuticals (AERI) came up with great news about its glaucoma treatment. The stock surged ….   On February 18, 2016, Under News & Comments, we wrote an article titled “Aerie Pharmaceuticals: Novel Glaucoma Eye Drops Confirm their Superiority”. The article also referred to a Prohost previous article written on February 4, 2015 and tittled “Aerie Pharmaceuticals …

Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced positive results from the BRIDGE pivotal Phase 3 placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis.  The study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine in men with osteoporosis treated with romosozumab compared with placebo at 12 months. All secondary endpoints comparing romosozumab with placebo …

On February 4, 2015, we wrote an article titled, “Aerie Pharmaceuticals is speeding towards improving the treatment of glaucoma”, posted under News & Comments at the Prohost website, we wrote the following: YOUNG BUT STRONG COMPETITOR IN THE GLAUCOMA HUGE MARKET Aerie Pharmaceuticals has eye drops that could become a game changer in the management of glaucoma. The firm’s lead drug, Rhopressa™, is a one drop once-daily …

Aerie Pharmaceuticals (AERI), which is specialized in glaucoma treatments reported successful results of its second Phase 3 trial for Rhopressa™ — a novel once-daily, triple-action eye drops for glaucoma. The trial achieved its primary efficacy endpoint demonstrating non-inferiority of Rhopressa™ compared to timolol, the most widely used comparator. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. …

AERIE PHARMACEUTICALS (AERI) A YOUNG BUT STRONG COMPETITOR IN THE GLAUCOMA HUGE MARKET – Aerie Pharmaceuticals has eye drops that could become a game changer in the management of glaucoma. – The firm’s lead drug, Rhopressa™, is a one drop once-daily having triple action that might bring life to over two decades of paralysis in Glaucoma treatments. – Rhopressa™ inhibits Rho Kinase (ROCK) and the …