The Daily Biotech Pulse: Merck's Keytruda Snags Another FDA Approval, DBV Announces Positive Peanut Allergy Study Findings, Applied Genetic Soars On Trial Results

The following is a roundup of top developments in the biotech space over the last 24 hours. 

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Jan. 8.)

• Allergan plc AGN: AbbVie Inc ABBV announced plans to integrate Allergan, which it has agreed to acquire
• Applied Therapeutics Inc APLT (announced positive results for the midstage study of its experimental drug to treat inherited galactose processing disorder)
• Collegium Pharmaceutical Inc COLL (announced upbeat guidance for fiscal year 2020)
• Bio-Rad Laboratories, Inc. Class A BIO
• Dermira Inc DERM
• DexCom, Inc. DXCM
• Grifols SA - ADR ADR Class B GRFS
• Inspire Medical Systems Inc INSP
• Medtronic PLC MDT
• Nevro Corp NVRO
• NuVasive, Inc. NUVA (SunTrust initiated coverage of the stock with a Buy rating)
• PTC Therapeutics, Inc. PTCT
• Syneos Health Inc SYNH
• TG Therapeutics Inc TGTX
• Turning Point Therapeutics Inc TPTX
• Vertex Pharmaceuticals Incorporated VRTX
• Zoetis Inc ZTS

None of the NYSE- or Nasdaq-listed biotech hit 52-week lows Wednesday.

Stocks In Focus

Medtronic Buys Spinal Cord Stimulation Tech Company Stimgenics

Medtronic said it has acquired Illinois-based, privately held Stimgenics, a pioneer of novel spinal cord stimulation waveform known as Differential Target Multiplexed Spinal Cord Stimulation.

"The therapy, which is delivered via the Medtronic Intellis platform, is a new and unique programming option to treat patients with chronic pain," Medtronic said.

The company expects the acquisition to be neutral to fiscal year 2020 earnings per share and to meet its long-term financial metrics for acquisitions.

Merck's Keytruda Approved As Monotherapy For Bladder Cancer

Merck & Co., Inc. MRK announced FDA approval for its Keytruda as monotherapy for treating patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Merck shares were trading 0.56% higher at $89.10 in Thursday's premarket session. 

Applied Genetic Reports Positive Results For Gene Therapy Targeting Inherited Eye Disorder

Applied Genetic Technologies Corp AGTC released positive interim six-month data for its ongoing Phase 1/2 study of its AAV-based gene therapy in X-linked retinitis pigmentosa.

Patients treated centrally with its product candidate showed durable improvement in visual function six months after dosing, the company said.

The data, along with the promising safety and efficacy data reported in September 2019, will help design the pivotal trial that Applied Genetics plans to initiate by the end of 2020.

Applied Genetic also said it would report interim six-month data from the dose escalation cohorts of both of its ongoing trials in achromatopsia later this month.

The stock was rallying by 51.44% to $6.30 at the time of publication Thursday. 

See also: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

Globus Medical Guides To FY20 Revenue, EPS Shortfall

Globus Medical Inc GMED announced preliminary fourth-quarter and full-year results and said it expects fourth-quarter sales of $211 million and full-year sales of $784.7 million.

Analysts, on average, expect revenue of $209.93 million for the fourth quarter and $783.95 million for the full year.

For 2020, the company expects revenue of $850 million and non-GAAP EPS of $1.82, trailing the consensus estimates of $854.39 million in revenue and $1.92 in EPS.

The stock was down 6.02% at $55 in the premarket session. 

DBV Reports Positive Study Results For Peanut Allergy Drug In Children

DBV TECHNOLOGIE/S ADR DBVT announced positive results for the three-year, open-label extension study of the Phase 3 PEPITES trial that evaluated the long-term efficacy and safety of its investigational Viaskin Peanut in peanut-allergic children ages 4-11. 

"The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose, which may decrease the chance of reacting to an accidental peanut exposure," the company said.

The stock was trading 21% higher at $13.70 at the time of publication. 

Mirati Announces $250M Secondary Offering

Mirati Therapeutics Inc MRTX said it intends to offer $250 million in common shares in an underwritten public offering. 

The stock was down 5.9% at $98.56 in the premarket session Thursday. 

Nabriva's Contepo NDA Resubmission Accepted For Review

Nabriva Therapeutics PLC – ADR NBRV said the FDA acknowledged the receipt of its NDA resubmission for Contepo injection for the treatment of complicated urinary tract infections, or cUTIs. The PDUFA date has been set for June 19, 2020.

The FDA handed down a complete response letter for the Contepo NDA in cUTIs on April 30, 2019, after which the company had a Type A meeting with the regulatory agency. The FDA then classified the resubmission as Class 2, giving a six-month review period from the date of resubmission.

Nabriva shares were trading 6.5% higher at $1.31 in Thursday's premarket session. 

AEterna Zentaris Violates Minimum Bid Price Listing Standard

AEterna Zentaris Inc. AEZS said it has received a notification from the Nasdaq that the company no longer meets the minimum bid price requirement, as its shares were trading below $1 for 30 consecutive business days.

The stock was trading down 5.41% at $1.05 in the premarket session. 

Related Link: 8 Biotech Stocks Morgan Stanley Recommends For 2020