The Daily Biotech Pulse: Horizon Pharma Under DoJ Radar, FDA Greenlights J&J's Depression Drug, Endologix Reverse Split

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 March 5)

• AstraZeneca plc AZN
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Chiasma Inc CHMA
• Qiagen NV QGEN
• Osiris Therapeutics, Inc. OSIR

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 5)

• Novavax, Inc. NVAX
• OncoSec Medical Inc ONCS

Stock In Focus

Immutep's Skin Cancer Drug Aces Early-stage Trial

Australian biotech IMMUTEP LTD/S ADR IMMP, which focuses on novel immunotherapy treatment for cancer and autoimmune disease, announced positive, more mature data for the Phase 1 trial of its lead candidate eftilagimod alpha, which is being evaluated in combination with Merck & Co., Inc. MRK's Keytruda for treating unresectable or metastatic melanoma.

The stock rallied 11.11 percent to $2.70 in after-hours trading.

Horizon In Receipt Of DoJ Investigative Demand Related To PBM Payments

Horizon Pharma PLC HZNP said in a filing the Department of Justice has made a civil investigative demand regarding assertions that certain of its payment to pharmacy benefit managers, or PBMs, were in violation of the anti-Kickback Statue. The request related to payments to PBMs, pricing and the company's patient assistance program regarding its Duexis, Vimovo and Pennsaid 2 percent.

"While we believe that our payments and programs are compliant with the Anti-Kickback Statute, no assurance can be given as to the timing or outcome of the DOJ's investigation, or that it will not result in a material adverse effect on our business," the company said in the filing.

The stock moved down 3.75 percent to $26.20 in after-hours trading.

FDA Accepts Roche's sNDA For Xofluza To Treat Flu

Roche Holdings AG Basel ADR RHHBY said the FDA has accepted a sNDA for Xofluza as a single-dose oral treatment for people at high risk of complications from the flu.

The sNDA is based on results from the late-stage CAPSTONE-2 study of a single dose of Xofluza compared with placebo or oseltamivir 75 mg, twice daily for five days, in people 12 years of age or older who are at high risk of complications from the flu.

The PDUFA date has been set for Nov. 4.

See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

J&J Gets FDA Nod For Treatment-resistant Depression Drug

Johnson & Johnson JNJ's Janssen unit said the FDA approved Spravato, chemically Esketamine CIII nasal spray, to be used in conjunction with an oral antidepressant in adults with treatment-resistant depression.

The company noted that the drug carries a Boxed warning, regarding a REMS and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.

"Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy," the FDA said in a statement.

Last month, a FDA panel had voted 14-2 in favor of the benefit-risk profile.

Endologix Shares To Begin Trading On Reverse-Split Adjusted Basis

Endologix, Inc. ELGX said the ratio of its previously-announced reverse stock split of its outstanding shares has been fixed at 1-for-10. Beginning with the opening of trading March 6, the shares will trade on the NASDAQ on a reverse stock split-adjusted basis.

The stock, which begins to trade on a split-adjusted basis, dropped 90.76 percent to 61 cents.

Offerings

CymaBay Therapeutics Inc CBAY commenced an underwritten public offering of its common stock. All shares are to be sold by the company. The company said it intends to use the net proceeds to fund the ongoing development of seladelpar and for working capital and general corporate purposes.

The stock slipped 5.12 percent to $12.60 in after-hours trading.

Sarepta Therapeutics Inc SRPT priced an underwritten public offering of an aggregate of 2.604 million shares at $144 per share. The offering is expected to close March 7.

The stock fell 3.89 percent to $143 in after-hours trading.

Titan Pharmaceuticals, Inc. common stock TTNP filed a preliminary short form prospectus with the securities regulators in the provinces of Ontario, British Columbia and Alberta and a corresponding registration statement on Form F-10 with the U.S. SEC in connection with a proposed marketed offering of units to raise total gross proceeds ranging between $20 million and $25 million.

Each unit will be comprised of one common share and one common share purchase warrant, the company said.

The stock declined 7.94 percent to $3.48 in after-hours trading.

On The Radar

Earnings

• GlycoMimetics IncNASDAQ: (GLYC) (before the market open)
• Jounce Therapeutics Inc JNCE (before the market open)
• Orthopediatrics Corp KIDS (before the market open)
• OptiNose Inc OPTN (before the market open)
• Xenon Pharmaceuticals Inc XENE (after the market close)
• Assertio Therapeutics Inc ASRT (after the market close)
• CareDx Inc CDNA (after the market close)
• Evoke Pharma Inc EVOK (after the market close)
• Kindred Biosciences Inc KIN (after the market close)
• Xenon Pharmaceuticals Inc XENE (after the market close)