Not yet fully emerged from stealth mode, Sideris Pharmaceuticals Inc. made known its $32 million Series A round as well as a potential $300 million deal with Novartis AG that includes the right to acquire Sideris and the iron-chelating candidate SP-420.
“Best case scenario” was the phrase flying around after last week’s approval of Actelion Ltd.’s Opsumit (macitentan), the next-generation dual endothelin receptor antagonist (ERA) for pulmonary arterial hypertension.
Specific guidance for companies aiming to more quickly develop drugs for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) will be available next year from the FDA, said Janet Maynard, from the agency’s office of pulmonary, allergy and rheumatology products.
The first therapy for pulmonary arterial hypertension to be approved on endpoints measuring patient function rather than outcomes such as the six-minute walk test won the FDA’s blessing Friday.
Cancer immunotherapy gained another stamp of approval with the $23 million in gross proceeds raised by Advaxis Inc., which sold about 5.7 million shares plus warrants to buy about 2.8 million more, at a price of $4 per share and $0.01 per warrant.
Favorable topline data from Regeneron Pharmaceuticals Inc. and partner Sanofi SA’s first of a dozen Phase III trials with alirocumab for high cholesterol gave cause for encouragement, but investors must wait for full details regarding the results, as well as adverse events (AEs).
Climbing into the ring with one of the harder – albeit rare – cancers to beat, Atterocor Inc. started a Phase I trial with ATR-101, designed to selectively cause apoptosis in adrenal cell carcinoma (ACC).
“Caveat emptor” is a warning hardly needed by seasoned investors in biotech, many of whom understand the failure-fraught industry and are cautious buyers, when they can be persuaded to buy at all.
While pundits argue over whether the lately upbeat mood for initial public offerings (IPOs) represents a “bubble” or a “boom,” another two biotech firms took the opportunity to file for their chances at the mild frenzy this year.