Nasdaq has suspended trading in DURECT (NASDAQ:DRRX) pending the release of news, in this case, the outcome of an FDA advisory committee meeting today on bupivacaine extended-release solution for post-surgical analgesia.
Thursday, January 16, 2020
TG Therapeutics initiates umbralisib application in U.S.
Glaxo down 2% in Europe on Barclays cut
GlaxoSmithKline (NYSE:GSK) slips 2% in London after Barclays cut its rating to Underperform with a 1,650 pence (9% downside risk) price target.
Barclays says sales growth this year looks challenging with a slight drop in expected earnings, adding that its multiple myeloma drug may be an also-ran compared to offerings from Celgene and Regeneron Pharmaceuticals.
Its forecast is 57% below the consensus for 2023.
Shares down 1% premarket in the U.S. on light volume.
BioNTech to acquire Neon Therapeutics in all-stock deal
BioNTech SE (NASDAQ:BNTX) has agreed to acquire Neon Therapeutics (NASDAQ:NTGN) in an all-stock transaction valued at ~$67M ($2.18/share). Under the terms of the deal, Neon shareholders will receive 0.063 of a BNTX ADS for each NEON common share held.
Neon’s lead candidate is NEO-PTC-01, a personalized neoantigen-targeted T cell therapy.
FDA OKs ANI Pharma drug for kidney stones
The FDA has approved ANI Pharmaceuticals’ (NASDAQ:ANIP) marketing application for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq for the management of renal tubular acidosis with calcium stones (kidney stones), hypocitraturic calcium oxalate nephrolithiasis of any etiology and uric acid lithiasis with or without calcium stones.
Per IQVIA, the U.S. market is ~$75M.
Arena Pharma’s APD418 Fast Track’d in U.S. for heart failure
The FDA designates Arena Pharmaceuticals’ (NASDAQ:ARNA) APD418 for Fast Track review for the treatment of decompensated heart failure (a sudden worsening of signs and symptoms, including difficulty breathing, fatigue and swelling in the legs and feet).
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
The company says Phase 1-stage APD418 is a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope designed to improve cardiac contractility without the unwanted effects on heart rate, blood pressure and myocardial oxygen consumption associated with inotrope therapies.
Wednesday, January 15, 2020
I-Mab IPO: What You Need to Know
The 2-year lull in the U.S. listing of Chinese biotechs is expected to end this week, with the upcoming IPO of I-Mab.
The IPO Terms
Shanghai-based I-Mab, a clinical-stage biopharma company, has filed to offer 7.41 million ADSs representing 17.04 million ordinary shares in an IPO, according to an amended filing with SEC.
The company expects to price the offering between $12 and $15 per ADS. It has applied for listing its ADSs on the Nasdaq under the ticker symbol IMAB.
At the midpoint of the price range, the offering is expected to raise gross proceeds of $100 million.
Jefferies and CICC are the lead underwriters for the IPO, with China Renaissance and Huatai Securities serving as co-managers.
The Company
I-Mab is focused on the development of biologics, primarily for cancers and autoimmune disorders. The company has a rich pipeline, with five licensed assets, which are in varying stages of clinical trials.
These apart, the company also has a few proprietary compounds in development either in pre-clinical or early-stage clinical trials.
The most-advanced compound in its pipeline is TJ202, a differentiated CD38 antibody it has licensed from Morphosys Ag MOR 2.91%. TJ202 is being evaluated for multiple myeloma or autoimmune disorders.
Source: F1/A filing
The Finances
I-Mab generates revenues from licensing and collaboration and is yet to turn in a profit.
For the 9-month period ended Sept. 2019, the company reported revenues of $4.197 million, down about 31% year-over-year.
The net loss for the period widened from $6.11 per share to $21.49 per share.
The net loss for the period widened from $6.11 per share to $21.49 per share.
Subscribe to:
Posts (Atom)