Weekly biotech pulse: X4 Pharma data on deck, AbbVie set for FDA review

Investing.com — Here is your weekly Pro Recap preview of key biotech and FDA catalysts to look out for in the next week: new data from X4 Pharma, upcoming review dates for Krystal Biotech, and a torrent of news set for release at an annual biotech conference.

When this news comes out, InvestingPro users will be getting word of it in real time. Start your 7-day free trial to see for yourself.

Investors hyped up for fresh X4 Pharmaceuticals data

Keep an eye on X4 Pharma (NASDAQ:) on Tuesday, as the company is set to host a presentation of additional Phase 3 data for mavorixafor, its candidate for WHIM Syndrome.

The company had already reported positive Phase 3 results for the drug back in November 2022, and mavorixafor achieved both primary and key secondary endpoints. Nonetheless, investors appear hyped up for the upcoming presentation, as shares have rocketed 80% since early April.

XFOR said it remains on track to submit a New Drug Application (NDA) to the FDA early in the second half of 2023. The stock currently has 11 Buy ratings from various analysts with an average price target of $3.50.

Shares were recently changing hands at $1.47.

Krystal Biotech’s upcoming PDUFA date

Krystal Biotech (NASDAQ:) is gearing up for the PDUFA of B-VEC, its candidate to treat Epidermolysis Bullosa, on Friday. The company previously had the review date of Feb. 17, although that got pushed back to this coming Friday, May 19, following submission of additional manufacturing data to the FDA.

Heading into the decision, shares are up about 15% year to date to $88.16.

A total of 12 analysts currently cover the company, all with a Buy rating, and an average price target of $115.

Most recently, Stifel initiated coverage with a $102 price target, and called the B-VEC readout an “important milestone that we think warrants optimism.”

Drug from Genmab and AbbVie set for review

Another PDUFA is scheduled for next weekend: Epcoritamab, a drug co-developed by AbbVie (NYSE:) and Genmab (NASDAQ:) to potentially treat diffuse large B-cell lymphoma, commonly known as DLBCL, is set for review next Sunday.

ABBV currently has 19 Buy ratings, 13 Holds, and 2 Sells. Its shares are down some 9% year to date to $147.15.

Genmab is up 3% from the start of the year to $41.69.

A raft of news set for release at the ASGCT annual meeting

Last, but not least, American Society of Gene Cell Therapy (ASGCT) will be holding its 26th annual meeting from Tuesday to Saturday, and multiple companies are set to provide updates and release new data bits over the course of the meeting – which InvestingPro subscribers will receive in real time:

Tuesday, May 16:

• 2Seventy Bio (NASDAQ:) will present Phase 1 data on SC-DARIC33 for treatment of Acute Myeloid Leukemia (AML).

Wednesday, May 17:

• Cellectis (NASDAQ:) will present AMELI-01 data for treatment of Acute Myeloid Leukemia (AML).

Thursday, May 18:

• Cabaletta Bio (NASDAQ:) will present Phase 1 data for DesCAARTes in Pemphigus Vulgaris
• Rocket Pharmaceuticals (NASDAQ: NASDAQ:) to share additional Phase 1 data for RP-A501 in Danon Disease
• Ultragenyx (NASDAQ: RARE) to present Phase 1/2 data for DTV401 in Glycogen Storage Disease Type Ia (GSDIa)

Friday, May 19:

• Candel Therapeutics (NASDAQ:) to present new Phase 1 data on CAN-3110 in Glioma patients
• Orchard Therapeutics (NASDAQ:) to share initial Phase 3 data for OTL-203 in Mucopolysaccharidosis Type I (MPS-I).

Saturday, May 20:

• Orchard Therapeutics (NASDAQ:) to provide initial Phase 1/2 data for OTL-201 in Mucopolysaccharidosis Type 3 (MPS-IIIa).

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