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First rounds of FDA layoffs led by the new Health Secretary form uncertain environment

Sotio Biotech

1/4/2025 | 3 minutes to read

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The investors are concerned about how Federal workforce reductions would affect FDA and its ability to meet its PDUFA objectives. The Valentines Day massacre led by the new Health Secretary RFK led to chaos and uncertainty and vision of a biotech bull market seems increasingly difficult to conjure.

Monthly market moves of selected competitors compared to NASDAQ Biotechnology Index (NBI)

february_2025

Area

Company

Ticker

Price range $

Δ  Price

MktCap $m

Δ MktCap $m

ADC

ADC Therapeutics

ADCT

1.39 – 1.76

-16

%

162

-30

Elevation Oncology

ELEV

0.52 – 0.68

23

%

41

8

Mersana Therapeutics

MRSN

0.50 – 0.75

-57

%

70

-94

Sutro Biopharma

STRO

1.55 – 2.12

4

%

158

7

IL15 / 2

ImmunityBio

IBRX

2.86 – 3.90

35

%

2 404

620

Mural Oncology

MURA

3.66 – 4.47

16

%

64

9

Nektar Therapeutics

NKTR

0.66 – 1.06

-11

%

153

-19

Werewolf Therapeutics

HOWL

1.16 – 1.52

-9

%

60

-6

CAR-T

Allogene Therapeutics

ALLO

1.40 – 2.84

-15

%

377

-69

Arcellx

ACLX

60.26 – 68.56

-11

%

3 684

-463

Autolus Therapeutics

AUTL

1.73 – 2.17

-6

%

588

-37

Mustang Bio

MBIO

2.00 – 4.00

-51

%

206

-216

Other

Arcus Biosciences

RCUS

9.88 – 13.57

-13

%

1 180

-182

Immutep

IMMP

1.88 – 2.04

-4

%

304

-12

MacroGenics

MGNX

2.40 – 2.98

-8

%

188

-16

ADC Therapeutics 

ADCT’s CEO Ameet Mallik participated in a fireside chat at the Guggenheim SMID Cap Biotech Conference. 

Elevation Oncology 

Elevation announced that members of management will participate in TD Cowen 45th Annual Health Care Conference and in Leerink Global Biopharma Conference.

Mersana Therapeutics 

Mersana announced that members of management participated in a fireside chat at the Guggenheim SMID Cap Biotech Conference.

Sutro Biopharma 

Short interest of Sutro increased by 15 % to 4,412,213 reported on February 14, compared to 3,850,554 on January 15.

ImmunityBio 

ImmunityBio announced the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving SOC chemotherapy or radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer. 

Mural Oncology 

Short interest of Mural decreased by 23 % to 406,088 reported on February 14, compared to 530,235 on January 15.

Nektar Therapeutic 

Nektar announced that FDA has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis. The company also announced it has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata. 

Werewolf Therapeutics 

Werewolf announced the appointment of Anil Singhal PhD, President and CEO of Trishula Therapeutics, as a member of its board of directors.

Allogene Therapeutics 

Allogene announced an expanded strategic collaboration with Foresight Diagnostics to include the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma for treatment with cemacabtagene ansegedleucel.

Autolus Therapeutics 

Short interest of Autolus increased by 13 % to 9,491,664 reported on February 14, compared to 8,381,606 on January 15. 

Arcellx 

Arcellx reported in its annual report net loss of $47 million and $20 million for the 4Q 2024 and 2023, respectively. Net losses were $107 million and $71 million for the full year 2024 and 2023, respectively. 

Mustang Bio 

Mustang announced the closing of its previously announced public offering, for the issuance and sale of an aggregate of 2,657,807 shares of its common stock at a combined public offering price of $3.01 per share. The gross proceeds from the offering were approximately $8 million. The company also announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts and concurrent divestment of certain fixed assets including furniture and equipment to AbbVie Bioresearch Center for $1 million.

Arcus Biosciences 

Arcus presented new data from the ARC-20 study in an oral session at the 2025 ASCO Genitourinary Cancers Symposium. The presentation highlighted safety and efficacy data from three cohorts of ARC-20, which evaluated casdatifan monotherapy in patients that had received both prior TKI and anti-PD-1 therapy. The company separately announced that it retains rights to casdatifan, as Gilead’s window to exercise its option to casdatifan has expired. With this the company announced pricing of $150 million common stock offering to fund Arcus through the anticipated data readout for PEAK-1, the Phase 3 trial for casdatifan in the immuno-oncology-experienced ccRCC setting.

Immutep 

mmutep provided an update on its activities for the quarter ended December 2024. The company highlighted mature data from INSIGHT-003 in 1L NSCLC, which demonstrated an excellent 32.9-month median OS and 81.0% 24-month OS rate, significantly outperforming historical controls

MacroGenics 

MacroGenics announced that the company's management will participate in TD Cowen 45th Annual Healthcare Conference, Leerink Partners 2025 Global Healthcare Conference, and Barclays 27th Global Healthcare Conference. 

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