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Zacks News
HilleVax (HLVX) Tanks as Norovirus Vaccine Study in Infants Fails
by Zacks Equity Research
HilleVax's (HLVX) phase IIb NEST-IN1 study evaluating HIL-214 for preventing acute gastroenteritis caused by norovirus infection in infants fails to meet its primary efficacy endpoint. Stock falls.
Mirum (MIRM) Rises More Than 30% in Past 3 Months: Here's Why
by Zacks Equity Research
The recent label expansion of Mirum's (MIRM) lead drug, Livmarli, is expected to drive sales in the upcoming quarters. The company's efforts to build its pipeline beyond Livmarli also hold promise.
AstraZeneca's (AZN) Tagrisso Gets EU Nod for First-Line NSCLC
by Zacks Equity Research
The European Commission approves AstraZeneca's (AZN) Tagrisso in combination with chemotherapy for first-line treatment of advanced EGFR-mutated NSCLC based on data from the phase III FLAURA2 study.
GSK Buys Flu, COVID mRNA Jab Rights From Partner CureVac
by Zacks Equity Research
GSK revamps its existing collaboration deal with partner CureVac, converting it from a collaboration deal into a licensing agreement related to mRNA vaccine candidates for COVID-19 and influenza.
Vertex (VRTX) NDA for Vanza Triple Therapy Accepted by FDA
by Zacks Equity Research
The FDA accepts Vertex's (VRTX) new drug application for vanza triple therapy for people living with cystic fibrosis aged six years and above. A decision is due on Jan 2, 2025.
SpringWorks (SWTX) Completes NDA Submission for Mirdametinib
by Zacks Equity Research
SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with neurofibromatosis type 1- associated plexiform neurofibromas.
Intellia (NTLA) Shares Fall as CFO Glenn Goddard Steps Down
by Zacks Equity Research
Intellia (NTLA) appoints Edward Dulac as its new chief financial officer after Glenn Goddard steps down from his role with effect from Jun 30.
Beam Therapeutics (BEAM) Begins Dosing in Phase I/II AATD Study
by Zacks Equity Research
Beam Therapeutics (BEAM) doses the first patient in a phase I/II study, evaluating in vivo base editor BEAM-302 for treating alpha-1 antitrypsin deficiency.
Here's Why You May Invest in Theravance (TBPH) Stock Now
by Zacks Equity Research
Here, we discuss some reasons why investing in Theravance (TBPH) stock now may turn out to be a prudent move.
Corcept (CORT) Shares Rise 20% in Three Months: Here's Why
by Zacks Equity Research
Corcept's (CORT) pipeline progress has been encouraging with relacorilant currently under evaluation for Cushing's syndrome. The NDA for relacorilant is expected to be filed in the third quarter.
AbbVie (ABBV) Parkinson's Candidate Faces 2nd FDA Rejection
by Zacks Equity Research
AbbVie (ABBV) issues the second CRL for Parkinson's disease medicine, ABBV-951, based on some observations on inspection of one of its third-party manufacturing facilities.
Alimera (ALIM) Rises on Merger Deal With ANI Pharmaceuticals
by Zacks Equity Research
Alimera (ALIM) is set to be acquired by ANI Pharmaceuticals for approximately $381 million in upfront consideration. The transaction is expected to close in the third quarter of 2024.
GSK's Filing for Expanded Use of Jemperli Gets EMA Acceptance
by Zacks Equity Research
The European Medicines Agency accepts GSK's application for the expanded use of Jemperli plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer.
J&J (JNJ) Seeks Expanded Use of Tremfya for Crohn's Disease
by Zacks Equity Research
J&J (JNJ) seeks label expansion for Tremfya for treating moderately to severely active Crohn's disease. This marks the second sBLA filing for Tremfya in three months.
AstraZeneca's (AZN) Truqap Gets EU Nod for Breast Cancer
by Zacks Equity Research
The European Commission approves AstraZeneca's (AZN) Truqap in combination with Faslodex for ER-positive, HER2-negative advanced or metastatic breast cancer.
Mirum (MIRM) Soars on Interim Data From Liver Disease Studies
by Zacks Equity Research
Mirum (MIRM) posts positive interim data from two phase IIb studies evaluating volixibat in patients with primary biliary cholangitis and primary sclerosing cholangitis. Stock rises.
AstraZeneca's (AZN) Truqap Misses Endpoints in TNBC Study
by Zacks Equity Research
AstraZeneca's (AZN) phase III CAPItello-290 study evaluating Truqap plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer fails to meet the dual primary endpoints.
AstraZeneca's (AZN) Imfinzi Gets FDA Nod in Expanded Use
by Zacks Equity Research
The FDA approves AstraZeneca's (AZN) Imfinzi in combination with chemotherapy for treating mismatch repair deficient advanced/recurrent endometrial cancer based on data from the phase III DUO-E study.
Repligen (RGEN) Promotes CCO, Shares Fall on Leadership Change
by Zacks Equity Research
Repligen (RGEN) appoints Olivier Loeillot as the company's new president and chief executive officer, effective from Sep 1, 2024. Stock falls on the news.
Down -15.94% in 4 Weeks, Here's Why Rapt Therapeutics (RAPT) Looks Ripe for a Turnaround
by Zacks Equity Research
Rapt Therapeutics (RAPT) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.
Rapt Therapeutics (RAPT) Loses -47.08% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
by Zacks Equity Research
Rapt Therapeutics (RAPT) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.
Here's Why Rapt Therapeutics (RAPT) is Poised for a Turnaround After Losing -52.88% in 4 Weeks
by Zacks Equity Research
The heavy selling pressure might have exhausted for Rapt Therapeutics (RAPT) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
Should You Buy RAPT Therapeutics (RAPT) Ahead of Earnings?
by Zacks Equity Research
RAPT Therapeutics (RAPT) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.
The Zacks Analyst Blog Highlights Moderna, RAPT Therapeutics, Iovance, Sarepta Therapeutics and Regeneron
by Zacks Equity Research
Moderna, RAPT Therapeutics, Iovance, Sarepta Therapeutics and Regeneron are included in this Analyst Blog.
Biotech Stock Roundup: MRNA's Q4 Results, RAPT Down on Study Results & Other Updates
by Zacks Equity Research
Earnings from Moderna (MRNA) and pipeline update from RAPT are in focus in the biotech sector.