The Daily Biotech Pulse: Pfizer And Allergan Earnings, CFO Departures At Acadia And Assertio

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Oct. 29)

• Gamida Cell Ltd GMDA
• NeoGenomics, Inc. NEO

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 29)

• Akari Therapeutics PLC AKTX
• Arcus Biosciences Inc RCUS
• BIOLINERX Ltd/S ADR BLRX
• BioSig Technologies Inc BSGM
• BioXcel Therapeutics Inc BTAI
• bluebird bio Inc BLUE
• Celldex Therapeutics, Inc. CLDX
• Clovis Oncology Inc CLVS
• CTI BioPharma Corp CTIC
• Elanco Animal Health Inc ELAN
• Exelixis, Inc. EXEL
• Fennec Pharmaceuticals Inc FENC
• Five Prime Therapeutics Inc FPRX
• Forward Pharma A/S FWP
• Immune Design Corp IMDZ
• IntelliPharmaCeutics Intl Inc IPCI
• Jounce Therapeutics Inc JNCE
• Melinta Therapeutics Inc MLNT(announced positive results for its Phase 3 study of Baxdela for treating adult patients with community-acquired bacterial pneumonia )
• Nabriva Therapeutics PLC – ADR NBRV
• Nightstar Therapeutics PLC NITE
• Pieris Pharmaceuticals Inc PIRS
• Progenics Pharmaceuticals, Inc. PGNX
• Regulus Therapeutics Inc RGLS
• Reshape Lifesciences Inc RSLS
• Ritter Pharmaceuticals Inc RTTR
• Scpharmaceuticals Inc SCPH
• Selecta Biosciences Inc SELB
• Sonoma Pharmaceuticals Inc SNOA
• Spring Bank Pharmaceuticals Inc SBPH
• SUMMIT THERAPEU/S ADR SMMT
• TG Therapeutics Inc common stock TGTX
• Unum Therapeutics Inc UMRX
• Vascular Biogenics Ltd VBLT
• ZEALAND PHARMA/S ADR ZEAL
• Zynerba Pharmaceuticals Inc ZYNE

Stocks In Focus

Acadia, Assertio Announce CFO Departures

ACADIA Pharmaceuticals Inc. ACAD announced CFO Todd Young will leave the company, effective Oct. 31, to join another health care company. Acadia's SVP Investor Relations will serve as its interim CFO.

The stock slipped 2.75 percent to $20.52 in after-hours trading

Assertio Therapeutics IncASRT said CFO Philip Donenberg will retire, effective Nov. 30, and company insider Daniel Peisert has been appointed as Donenberg's replacement.

The stock fell 5.63 percent to $5.03 in after-hours trading.

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

vTv Therapeutics To Transfer Listing to the Nasdaq Capital Market

vTv Therapeutics Inc VTVT announced the receipt of approval for the transfer of its securities from the Nasdaq Global Market to the Nasdaq Capital Market at the opening of business on Oct. 30, 2019. This follows Nasdaq's determination that the company's shares no longer satisfied the minimum market value of listed securities requirement. Pursuant to this, the company had applied for the transfer of listing to the Nasdaq Capital Market.

The shares will continue to trade under the ticker symbol VTVT.

The stock gained 4.82 percent to $3.04 in after-hours trading.

BioXcel Updates On Lead Neuroscience Program

BioXcel Therapeutics said it is advancing its lead neuroscience program BXCL501 into clinical trials, with the company planning to initiate an IND-opening Pharmacokinetic and safety study by the end of the year, following the approval of the IND application.

BXCL501 is a sublingual thin film formulation of dexmedetomidine hydrochloride being evaluated for acute treatment of agitation.

"We expect to report data from this study in the first half of 2019, laying the foundation for a registration trial that will follow," the company said.

Earnings

Medpace Holdings Inc MEDP reported Q3 revenues of $179.3 million and adjusted net income of 67 cents per share, ahead of the 62 cents per share consensus estimate. For the full year, the company guided net service revenues of $474.0 million to $479.0 million and non-GAAP net income per share of $2.76-$2.82, while analyst estimate $2.43 for the year.

The stock rose 5.41 percent to $49.51 in after-hours trading.

On The Radar

Earnings

Allergan plc AGN Q3 EPS $4.25 Beats $4.02 Estimate, Sales $3.91B Beat $3.86B Estimate
BIO-TECHNE Corp TECH Q1 EPS $0.98 Beats $0.94 Estimate, Sales $162.97M Beat $161.67M Estimate
Blueprint Medicines Corp BPMC Q3 EPS $(1.66) Misses $(1.51) Estimate, Sales $1.095M Miss $6.86M Estimate
Pfizer Inc. PFE Q3 EPS $0.78 Beats $0.75 Estimate, Sales $13.298B Miss $13.55B Estimate
Incyte Corporation INCY Q3 EPS $0.38 Misses $0.40 Estimate, Sales $429.683M Miss $450.38M Estimate
Insmed Incorporated INSM Q3 EPS $(1.14) Misses $(1.06) Estimate
Amgen, Inc. AMGN (after the market close)
Acceleron Pharma Inc XLRN (after the market close)
EXACT Sciences Corporation EXAS (after the market close)
Clovis Oncology (after the market close)
NeoGenomics

PDUFA Date

Merck & Co., Inc. MRK awaits FDA approval for Keytruda along with carboplatin-paclitaxel or nab-paclitaxel for first-line treatment of metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression. The PDUFA date is set for Tuesday, Oct. 30.

Histogenics Corp HSGX has a meeting scheduled with the FDA regarding BLA filing for its NeoCart, being tested to treat cartilage defects in the knee.