Benzinga's Daily Biotech Pulse: Merck's Keytruda Found Effective, Nabriva To Acquire Zavante, FDA Denies Agile

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on July 23)

• AstraZeneca plc (ADR) AZN(Sold rights to heart drugs Atacand and Atacand Plus to Cheplapharm for an upfront payment of $200 million, a time-bound payment of $10 million and sales-contingent milestones)
• Baxter International Inc BAX
• Becton Dickinson and Co BDX
• Biogen Inc BIIB(reported forecast-beating Q2 results and raised its FY18 earnings guidance)
• Bio-Rad Laboratories, Inc. BIO
• Medtronic PLC MDT
• Merit Medical Systems, Inc. MMSI(reported beat-and-raise quarter)
• Veracyte Inc VCYT(reported above-consensus Q2 results)

Down In The Dumps

(Stocks hitting 52-week lows on July 23)

• Agenus Inc AGEN
• Aileron Therapeutics Inc ALRN
• Catabasis Pharmaceuticals Inc CATB
• Cytori Therapeutics Inc CYTX
• Enzo Biochem, Inc. ENZ
• Fortress Biotech FBIO
• Genocea Biosciences Inc GNCA
• MeiraGTx Holdings PLC MGTX
• Nevro Corp NVRO
• Novan Inc NOVN
• Reshape Lifesciences Inc RSLS
• RXi Pharmaceuticals Corp RXII
• Sellas Life Sciences Group Inc SLS
• TESARO Inc TSRO
• VBI Vaccines Inc VBIV
• ZIOPHARM Oncology Inc. ZIOP

Stocks In Focus

Merck Reports Positive Results For Keytruda In Head and Neck Cancer

Merck & Co., Inc. MRK said the pivotal Phase 3 KEYNOTE-048 trial that evaluated its Keytruda as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma met a primary endpoint of overall survival.

Nabriva Acquires Zavante Therapeutics

Nabriva Therapeutics PLC – ADR NBRV announced acquisition of Zavante Therapeutics, a company focused on developing novel therapies to improve the outcomes of hospitalized patients, for an upfront payment of about 8.2 million of Nabriva shares, and potential milestone payments of up to $97.5 million.

The shares rose 4.55 percent to $3.45 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Results, Earnings And IPOs

FDA's Turns Down Agile's Appeal Regarding Twirla

Agile Therapeutics Inc AGRX announced that FDA's Office of Drug Evaluation III affirmed the stance of the Division of Bone, Reproductive and Urologic Products, or DBRUP, by denying the company's appeal to the complete response letter for Twirla, an investigational low-dose, once-weekly contraceptive patch.

The DBRUP raised concerns regarding the in vivo adhesion properties of Twirla preventing its approval, and said it cannot be addressed through the company's proposed patient compliance programs.

The company said it intends to appeal the Office of Drug Evaluation III decision to the Office of New Drugs.

The penny stock slumped 31.54 percent to 31 cents a share in after-hours trading.

Merit Medical, Veracyte to Offer Shares

Merit Medical Systems said it plans to offer 3.50 million shares in an underwritten public offering of common stock. The company expects to use the net proceeds from the offering to repay debt under its existing credit facility. Merit Medical stock fell 1.48 percent to $56.50 in after-hours trading.

Veracyte announced common stock offering of 5 million shares, will all the shares to be offered by the company. Veracyte fell 4.05 percent to $10.65 in after-hours trading.

On The Radar

Earnings

Laboratory Corp. of America Holdings LH Q2 EPS $2.98 Beats $2.94 Estimate, Sales $2.9B Beat $2.85B Estimate
Anika Therapeutics Inc ANIK
Gilead Sciences, Inc. GILD
Integra Lifesciences Holdings Corp IART Q2 EPS $0.60, Inline, Sales $366.19M Miss $368.31M Estimate
Varian Medical Systems, Inc. VAR
Vertex Pharmaceuticals Incorporated VRTX

IPO

Aquestive Therapeutics, a company focused on differentiated therapy products to address unmet medical needs, priced its upsized initial public offering of 4.5 million shares at $15. The shares will be listed on the Nasdaq under AQST.

Adcom Meeting

FDA's Pulmonary-Allergy Drugs Advisory Committee is set to discuss GlaxoSmithKline plc (ADR) GSK's sBLA for mepolizumab injection, which is evaluated as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease.

Clinical Trials

Biogen is scheduled to present Phase 2 data for its BAN2401 to treat Alzheimer's disease at the Alzheimer's Association International Conference. The data released July 5 showed that the treatment candidate slowed disease progression.

Clearside Biomedical Inc CLSD will present Phase 3 data (already released in March) for its Suprachoroidal CLS-TA to treat macular edema associated with non-infectious uveitis. The data is to be presented at the 36th annual meeting of the American Society of Retina Specialists.

FDA Tidbits

FDA released a statement, announcing its efforts in working with MONDELEZ INTERNATIONAL INCMDLZ, Pepperidge Farm and Flowers Foods, Inc. FLO to initiate voluntary recalls of certain products due to a potential risk of one of the ingredients being contaminated with Salmonella.