4 Biotechs Facing Do-or-Die Catalysts in December
As 2018 winds down, it’s not over for some biopharma companies. John Engle, writing for Seeking Alpha, takes a look at four biopharma companies that have big catalysts this month.
Based in San Diego, Adamis focuses on developing and commercializing therapeutics for respiratory disease and allergies. On Dec. 4, Adamis submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to start testing naloxone in human patients. It is also planning to develop a naloxone injection product candidate using its patented Symject syringe drug platform. Naloxone is an opioid antagonist used to treat narcotic overdoses.
This followed a string of other announcements. Its Symjepi injector for epinephrine is a potential competitor to Mylan’s EpiPen. On Nov. 29, it submitted a prior approval supplement for its juvenile version of Symjepi. And on Dec. 1, it said it would be presenting the results of a study showing that Symjepi was more intuitive than other injectors.
Engle writes, “While the battery of news announcements were welcome signs of life from a company that has been radio silent for months, no one will be satisfied until a partner is announced for the commercialization of Symjepi. Trading around $4 a share, Adamis has been hurt by six months of immobility…. As we enter the final weeks of 2017, there is still a very good chance the company will close on a partner.”
Headquartered in Tarrytown, New York, Progenics is focused on developing therapies and approaches to treating cancer. On Nov. 2, the company completed the rolling submission of its NDA for Azedra in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine cancers.
Engle writes, “Progenics is unique on this list insofar as it has two catalysts this month. The most crucial is the Azedra NDA. The company has expressed the expectation that the FDA will respond before the end of the year. If so, Azedra will be set on a course for PDUFA destiny and a final decision by the FDA whether to approve—a decision expected to come in the first half of 2018.”
The other catalyst is finalizing enrollment of the Phase III clinical trial of 1404, an imaging agent used to identify prostate cancer.
Located in Rockville, Maryland, Novavax focuses on developing vaccines. As part of its third-quarter financial report on Nov. 7, the company announced it had initiated a Phase I/II trial of its nanoparticle influenza vaccine. Engle writes, “While Novavax’s ultimate story of survival and prosperity will depend on the results of a pivotal Phase III trial of its maternal RSV vaccine (data to be released next year), a nearer-term focus has been on NanoFlu, the company’s proprietary flu vaccine. In preclinical trials, NanoFlu outperformed the market leader, Sanofi’s Fluzone HD. Early stage human trials are now underway and if the results are anything like those of the preclinical trial, then Novavax will have added a serious new arrow to its quiver.”
It expects to share topline data from the latest NanoFlu trial by the end of the year.
Headquartered in Redwood City, Calif., on Nov. 9, the FDA approved the company’s Cinvanti (aprepitant) for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy. And then on Dec. 4, the company announced it was issuing new shares to raise money to launch Cinvanti, as well as to continue marketing its first approved drug, Sustol.
Engel writes, “Unsurprisingly, the announcement received a rather negative response from the market with shares falling to $15.70 (nearly 8.5 percent) in after-hours trading. Depending on the pricing and amount to be raised, that price may fall further—pricing the offering much above $15.70 would be a challenge in the current market. Heron watchers should be on their guard and read with care the prospectus as soon as they can get a copy. The opportunity to buy into a company with significant growth prospects at a bargain price has arrived.”