Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks hitting 52-week highs on Oct. 24)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Oct. 24)
Stocks In Focus
Melinta Gets FDA Nod For Baxdela Label Expansion; Launch to Be Delayed Due to Liquidity Concerns
However, the company flagged liquidity concerns and said it is delaying the commercial launch of Baxdela for CABP until it gains some insight into its ability to secure additional sources of liquidity.
Melinta is co-developing the drug with Ligand Pharmaceuticals Inc. (NASDAQ:LGND).
Melinta shares tumbled 25.86% to $3.24 in after-hours trading.
See Also: Biotech Stock On The Radar: Assessing Mirati's Oncology Franchise With An Eye On Multiple Readouts
Aclaris Aces a Late-stage Study of Treatment For Common Warts
Aclaris Therapeutics Inc (NASDAQ:ACRS) announced positive results from a second Phase 3 study, dubbed THWART-1, of A-101 45% topical solution, an investigational drug for the potential treatment of common warts.
The company said the pipeline asset met the primary and secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts.
In September, the company announced positive results from the first Phase 3 study dubbed THWART-2, sending its shares higher by about 64%.
The company said these data will serve as a basis for an NDA filing.
The stock moved up 18.45% to $1.99 in after-hours trading.
PDL BioPharma Responds to Activist's Call For Review of Strategic Alternatives
In the letter, Selick said at the September board meeting, it has been resolved to engage an external financial advisor for providing an independent perspective.
Anchiano Says Chairman of The Board Hoffman Resigns
ANCHIANO THERAP/S ADR (NASDAQ:ANCN) said Stephen Hoffman, who served as chairman of the board, has stepped down from the board, effective immediately.
Astellas's Xospata Approved In Europe For Blood Cancer With Specific Mutation
Earnings
Gilead Sciences, Inc. (NASDAQ:GILD) reported third-quarter revenues that remained flat at $5.6 billion and non-GAAP earnings per share, or EPS, of $1.75 that exceeded estimates by a penny. The company raised the low-end of its 2019 product sales guidance slightly, while maintaining the upper end.
The stock slipped 1.70% to $64.88 in after-hours trading.
Illumina, Inc. (NASDAQ:ILMN)'s third-quarter revenues rose 6% to $907 million. The non-GAAP income of $1.93 per share was higher than the year-ago's $1.52 per share and the consensus of $1.40 per share. The company issued a strong full-year 2019 guidance
The stock fell 4.52% to $301.24 in after-hours trading, apparently reacting to soft microarray sales, the Investor Business Daily reported, citing Evercore ISI analyst Vijay Kumar.
Anika Therapeutics Inc (NASDAQ:ANIK) reported strong third-quarter revenues growth and an EPS-beat. The company also raised its full-year guidance.
The stock 8.02% to $58.62 in after-hours trading.
ResMed Inc. (NYSE:RMD) reported 16% revenue growth to $681.1 million and a better-than-expected non-GAAP EPS of 93 cents.
The stock rallied 10.39% to $141 in after-hours trading.
On The Radar
Clinical Trial Readouts
Abeona Therapeutics Inc (NASDAQ:ABEO) will present at the European Society of Gene and Cell Therapy 27th Annual Congress, Phase 1/2 data on ABO-102 for treating Sanfilippo syndrome type A.
IPOs
Phathom Pharmaceuticals, a biotech company working on in-licensed assets for treating gastrointestinal disorders, priced its upsized offering of 9.56 million shares at $19 per share, at the midpoint of the estimated price range of $18-$20. The company seeks to list its shares on the Nasdaq under the ticker symbol "PHAT."
Cabaletta Bio, which uses chimeric autoantibody receptor, or CAAR, T cells that selectively bind and eliminate B cells that produce disease-causing autoantibodies, priced its upsized 6.8-million share IPO at $11, below the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol "CABA."
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