Sarepta silent on FDA's riposte
Sarepta Therapeutics Inc. (NASDAQ:SRPT) declined to comment on Friday after FDA vigorously defended itself in front of the Duchenne muscular dystrophy (DMD) community over the agency's advice and treatment of the company's eteplirsen (AVI-4658). In a rare statement on a compound still in development, FDA said it has been consistent in the advice it has provided to Sarepta on the development and regulatory pathway for the phosphorodiamidate morpholino oligomer (PMO) targeting exon 51.
AbbVie looking for specialty deals
With 3Q14 earnings that beat guidance, AbbVie Inc. (NYSE:ABBV) CEO Richard Gonzalez said the pharma still has an appetite for M&A, but declared it's unlikely to find more $50 billion opportunities like the attempted inversion deal with Shire plc (LSE:SHP; NASDAQ:SHPG).
Aegerion trips on Juxtapid shortfall
Aegerion (NASDAQ:AEGR) plunged $14.02 (41%) to $20.19 on Friday as investors reponded to the company's FY14 guidance post-market on Thursday that fell short of expectations.
Chimerix rises with its bank account
Chimerix Inc. (NASDAQ:CMRX) gained $1.15 to $31.04 after completing its second big follow-on in 2014. The infectious disease company raised $105.9 million through the sale of 3.65 million shares at $29 in a deal underwritten by Morgan Stanley; JP Morgan; Cowen; Piper Jaffray; Stifel, Nicolaus; Cantor Fitzgerald; and Brean Capital.
Imago raises $26.5M series A
Myeloid malignancy company Imago BioSciences Inc. (San Francisco, Calif.) raised $26.5 million in a series A round led by Clarus Ventures. Frazier Healthcare; Amgen Ventures; and Merck Research Labs Venture Fund also participated. CEO Hugh Rienhoff did not disclose if the round was tranched, but told BioCentury it was "fully committed."
Virobay pulls IPO
Virobay Inc. (Menlo Park, Calif.) withdrew its proposed IPO on NASDAQ, citing market conditions. Earlier this month, the company amended its offering to sell 3.8 million shares at $12-$14. At $13, it would have raised $50 million and been valued at $169 million. Piper Jaffray; JMP Securities; Cantor Fitzgerald; and Summer Street Research Partners were underwriters.
PolyPid sets IPO terms
PolyPid Ltd. (Petach Tikva, Israel) amended its proposed IPO on NASDAQ and now plans to sell 1.8 million shares at $10-$12. At $11, PolyPid would raise $20 million and be valued at $103 million. Aegis Capital; MLV; and Chardan are underwriters.
Clarus Ventures named Barry Gertz a venture partner. He also will become chief medical advisor for Clarus portfolio company Relay Pharmaceuticals Inc., which finances late-stage clinical studies of pharma assets. Gertz previously was SVP of global clinical development at Merck & Co. Inc. (NYSE:MRK).
POLITICS & POLICY
Veloxis respectfully begs to differ with FDA
Veloxis Pharmaceuticals A/S (CSE:VELO) plunged DKK0.63 (31%) to DKK1.40 on Friday after the company said FDA's tentative approval of immunosuppressant Envarsus XR tacrolimus will not become finalized until exclusivity expires for Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503) on July 19, 2016.
Joseph Griffin joined regulatory consulting firm Greenleaf Health LLC as EVP of drug and biological drug products. He was associate director for policy development in the Office of Medical Policy at FDA's Center for Drug Evaluation and Research (CDER).